Clinical Trials Logo

Clinical Trial Summary

Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.


Clinical Trial Description

In this study, patients were "randomized" into one of 2 study groups described below. They agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. The active molecule is called Fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. The inactive jar contains the vehicle alone without Fibrostat.

The patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. The cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. The randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. Each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. The cream in both jars looks and smells the same. Neither the patient nor the study doctor knew which breast as receiving the active agent. In an emergency, this information was to be made available.

Participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a Rex® durometer at 1, 3, 6, and 12 weeks post op.

The researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side.

The patients could stop participating at any time. However, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. No serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. The results were revealed to patients at the completion of the 12 week trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03376620
Study type Interventional
Source University of Manitoba
Contact
Status Completed
Phase Phase 3
Start date September 2, 2011
Completion date July 15, 2016

See also
  Status Clinical Trial Phase
Terminated NCT03935594 - Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars Phase 2
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Recruiting NCT06033430 - Effectiveness of Dry Needling in Linear Scar Tissue N/A
Recruiting NCT03631368 - Treatment of Hypertrophic Scars With Intradermal Botox Phase 2
Completed NCT03630198 - Pain Outcomes Following Intralesional Corticosteroid Injections Phase 4
Recruiting NCT02168634 - The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial N/A
Completed NCT02030275 - A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults Phase 2
Recruiting NCT04506255 - Silicone Taping for the Improvement of Abdominal Donor Site Scars N/A
Not yet recruiting NCT04593706 - Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) N/A
Completed NCT04643223 - Effect of Elastic Bandage With Tension on the Inflammatory Response of Hypertrophic Scars N/A
Completed NCT03986346 - The Vascularity Changes of Scars With Laser Therapy N/A
Completed NCT04619589 - Characterization of Dyschromic Hypertrophic Scar
Completed NCT06347081 - Effect of Nd-YAG Laser on Hypertrophic Scar N/A
Completed NCT05412745 - Class I Medical Device on Post-surgical Scars N/A
Terminated NCT03403621 - Hypertrophic Scar Prevention by Novel Topical Gel Application Phase 1/Phase 2
Completed NCT00754247 - A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars Phase 4
Recruiting NCT03692273 - Randomized Control Trial of CO2 Laser to Treat Hypertrophic Burn Scar N/A
Completed NCT03795116 - Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention Phase 2
Not yet recruiting NCT03850119 - Nanofat on Wound Healing and Scar Formation N/A
Recruiting NCT04364217 - Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser N/A